Project Manager Resume
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Resume:
EILEEN RAYHON
Vones Lane • Bridgewater, New Jersey
–
Detail-oriented with experience in project management, clinical study start-ups, regulatory document maintenance, vendor and site management, and governmental regulation compliance.
&#; Quick learner with an ability to rapidly achieve organizational integration, easily assimilate job requirements and aggressively employ new ideas, concepts, methods and technologies.
&#; Energetic and self-motivated team player/builder. Effective in work situations requiring an ability to manage multiple and concurrent projects and responsibilities.
&#; Successful in prioritizing workflow, fielding and resolving internal staff and external customer issues, documenting required specifications for compliance with governmental agency regulations, and managing special projects.
&#; Exceptional communication, interpersonal, administrative, organizational, problem solving and leadership skills. Thrive in both independent and collaborative work environments.
PROFESSIONAL EXPERIENCE
Schering Plough – Kenilworth, NJ
Clinical Supply Manager (contracted position with Kinely and ManBeck) August - Present
Therapeutic area Oncology & Hepatitis
Work with Clinical Operations to forecast CTM needs, develop clinical supply plans, packaging configurations and distribution strategies.
Provide supporting documents and supplies
Develop labeling to meet study and regulatory requirements
Provide supply forecasts and requirements to the CPM team to ensure appropriate delivery schedules of drug product for clinical use
Work with manufacturing to resolve issues and support the packaging activities
Interact as needed with other clinical service providers
Creating options and strategies to meet needs and/or schedules as they evolve
Assist Clinical Operations as needed in distribution, handling complaints, returns and destruction of drug supply
Sanofi-Aventis – Bridgewater, NJ
Clinical Trial Coordinator (contracted position with Joule’ Scientific) July – June
Therapeutic area Metabolism
Provide support to the Global clinical study team (CRA’s, CTM’s and Directors)
Oversee therapeutic Trial Master Files, Set up and maintain working Trial Master Files in accordance with company SOPs.
Vendor payments, Prepare Purchase Order’s ensure that vendor payment request are made promptly in accordance with established budget. Track payments and works with finance for processing of vendor payments. Carrying out project related materials, coordinate approval process for reports, documents and agreements (CAF’s, CDA’s, CSA’s etc.) and tracks vendor contracts and review ICFs. Prepare and distribute agenda and meeting minutes for study team meetings. Distribute SAE information to sites according to ICH/GCPs. Maintain tracking database/tools to maintain investigator information IMPACT and PROFILE), SAP reconciliation, track clinical supply inventory, protocol deviation waivers, protocol violations, track regulatory trial master file documents. Assist with the organization of Investigator meetings. Provide coordination for investigator meetings, including completion of binder materials, meeting presentations and scheduling activities. Negotiate contracts and budgets, input of documents into GRESDA (document system).
Stryker Spine – Summit, NJ
Clinical Affairs Associate Dec – July
Orthopedic Device
Plan and carry out projects that support the Clinical Affairs Department, including identifying opportunities for process and procedure improvements, updating SOP’s and writing policies as needed. Calculate process and track payments/reimbursement for study conduct as defined by Clinical Trial Agreements; act as key contact for study sites regarding these payments.
Set-up and manage Trial Master Files and audit Regulatory documents, including tracking documents and working with Study Managers to ensure completeness of study and site specific files (IRB renewals, protocol acknowledgements, site correspondence, etc.). Revision control and release of clinical project documents (forms, labeling, etc). Conduct periodic review of Clinical SOP’s with applicable team members and update and release revisions. Assist in developing payment terms for clinical vendor and study site contracts as requested, track changes in terms; communicate any new changes to study managers and/or contracts group, as applicable. Set-up, process and track Clinical site billing/payments schedules and processes for, as applicable; completed CRFs, and Study coordinator hours. Initiate clinical study site payments and troubleshoot payment issues. Update and track employee training. Support Clinical Study Managers on projects
Key Achievements:
&#; Set up the Trial Master Files for different studies. Audit and track all regulatory and study documents.
I Research – Basking Ridge, NJ
Project Research Associate (contract position with i Resourcing) Oct – Nov
Therapeutic area HIV
Support study process to ensure adherence to protocol, SOPs, GCP/ICH Guidelines, applicable regulatory requirements, and other documentation requirements, including: Review, track, and manage study documents (e.g., eClinical reports, study supplies, study drug shipments, ICFs, and enrollment logs) for completeness and accuracy for filing into the Trial Master File.
Draft, compile and verify clinical data for status reports when required. Track and manage the distribution of study drug and clinical supplies as requested. Support compliance with study timelines. Assist with the management of vendors and associated data as requested. Assist the Project Manager and Lead Regional Clinical Research Associate (RCRA) in preparing the necessary tools to maintain consistency in the study data across all sites and regional monitors as requested.
Assist the Project Manager in study start-up activities and site recruitment, including: Contact sites to discuss study specifics. Track site interest regarding study participation. Send out site questionnaires and track results. Compile and distribute study binders. Assist in maintaining the project files. Communicate and interact with site staff, project team, and customer, including: Convey project information and answer questions. Support Regional CRAs as applicable. Support and follow up on study progress with site staff, other team members, and customer. Monitor vendors and other service providers for quality of service. Support preparation of key reports and documents on progress of study for Project Manager and customer review. Participate in customer teleconferences, draft and distribute the agenda and minutes. Train team members on project specific tasks as appropriate. Participate in in-house training programs and learning experiences as outlined in development plan. Perform other duties as assigned
GRUNENTHAL USA, Inc. – Bedminster, NJ
Clinical Research Associate (contract position with Tri Tech Associate) Aug, – Oct
Therapeutic area Oncology
Coordinate clinical study start-ups, site initiation, ensuring regulatory documents, contracts, IRB approvals for informed consent and site binders are on-site and adhere to strict FDA and governmental regulations. Review with site study information. Review criteria for patient enrollment and informed consent documents for appropriate language, adhering to Good Clinical Practice, HIPPA, and FDA guidelines. Monitoring of CINJ (Cancer Center Institute of NJ), CRF’s and documents. Follow randomize program and analyze study information identifying trends and report adverse events to management, site personnel and FDA regulators. Review of all regulatory documents for filing into the Trial Master File.
MITSUBISHI PHARMA AMERICA, Inc – Warren, NJ
Clinical Research Coordinator/Regulatory Document Specialist (contract position Clinical Brokers Group) Jan, -July,
Therapeutic area Central Nervous System
Provide in-house clinical support and oversight to the conduct of clinical trials documentation, work with Regulatory to make sure all study documentation is current and correct, Initiate a Trial Master File, and maintenance, assisting in the bullets and numbering of site-specific Ethics Committee (i.e., IRB) documents, performing activities similar to a document specialist, assisting with coordination of clinical trial support activities, maintaining regular contact with CRA’s in order to assure that documents relating to Trial Master File are collected which are organized and filed in the TMF appropriately. Adhering to Good Clinical Practice, HIPPA and FDA guidelines.
Key Achievements:
&#; Initiate and maintain a Trial Master File according to FDA regulatory guidelines
CORDIS CORPORATION (A Johnson & Johnson Company) –Warren, NJ Feb, -Jan,
Clinical Research Associate I (contract position through Kelly Scientific)
Therapeutic area Endovascular
Coordinate clinical study start-ups, site initiation, ensuring regulatory documents, contracts, IRB approvals for informed consent and site binders are on-site and adhere to strict FDA and governmental regulations. Review with sites study information. Review criteria for patient enrollment and informed consent documents for appropriate language, adhering to Good Clinical Practice, HIPPA, and FDA guidelines. In-house monitoring of CRF’s and documents. Establish trial master files for regulatory documents. Forecast, procure and account for all investigational devices. Conduct patient follow-up, tracking x-rays, CT’s and Ultrasounds. Analyze study information identifying trends and report adverse events to management, site personnel and FDA regulators.
Key Achievements:
&#; Regulatory Audit of studies for the Trial Master Files. Make sure regulatory and study documents are current and accounted for in the study.
&#; Coordinate over studies simultaneously, creating spreadsheets to track project metrics, budgets and supplies while adhering to strict deadlines.
&#; Currently manage a clinical device study with sites and enrolled patients.
&#; Promotion within months to Clinical Research Associate I
AVENTIS PHARMACEUTICALS – Bridgewater, NJ Dec -Feb
Special Event Coordinator / Senior Administrative Assistant
Organized special events, including product launch promotions to ensure employee knowledge of current product releases, holiday celebrations, and company meetings as an integral part of the Global Communications division. Sourced venues for special events and audio/visual equipment and planned refreshments. Interfaced with vendors to secure giveaways for product launches. Utilized company website, promotional posters and other internal communication devices to inform employees of upcoming events. Reviewed departmental budgets and executed payment for vendor invoices. Ensured internal communication devices met company standards, including color, font size, and logo positioning, interfacing with Germany headquarters on a consistent basis.
Key Achievements:
&#; Developed a comprehensive spreadsheet which tracked internal product launch posters by deployment and removal date based upon length of program for five separate off-site locations.
&#; Facilitated and coordinated the RPR merger event, including timing of executive speeches, vendor sourcing, and creation of product giveaways for new and existing employees.
BROTHER INTERNATIONAL / MERCK & CO. – Bridgewater / Somerset, NJ
Administrative Assistant
Assisted management team members with administrative tasks, including preparing and organizing departmental invoices and expense reports for accounts payable functions. Formulated internal and external correspondence and created presentations for client meetings and training programs. Input information into Delphi and Fox Pro databases.
WORLDCOM – East Rutherford, NJ
Regional Coordinator
Supervised two administrative assistants within the data sales department for the New Jersey, Pennsylvania and New York region. Coordinated the support of sales representatives and management, including sales figure tracking, creation of PowerPoint presentations, collateral development and handling travel arrangements and expense report review and submission. Formulated weekly payroll reports for the region.
EDUCATION
GCP, FDA Audit and GMP Training and
NJIT Web Author Certification –
Computer Applications and Business Communications Certification –
COMPUTER SKILLS
Proficient with Microsoft Word, Excel, PowerPoint, Visio, FrontPage, Outlook, Access, PhotoShop, Adobe Acrobat, Fox Pro, Delphi, CPDM, LotusNotes, EDC (electronic database)
